MAUDE Adverse Event Report: PRECISION MEDICAL INC EASY PULSE POC (PM4150); PORTABLE OXYGEN CONCENTRATOR

Model Number	PM4150
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The client that had this unit was mowing his yard; just like he had done many times before with the poc strapped onto his back like a backpack.Not sure how; but he said he had loosened the straps and it was resting on the back seat of the mower.It must have gotten too close to the muffler as that is what the client had stated, and it blew up & caught on fire.It scared the client to death but he was unharmed.Fortunately, he was close enough to the house that he was able to get inside and get on his concentrator.Patient notified provider ((b)(4)) of the incident.(b)(4) notified precision medical, inc.Precision medical inc issued an rga (return goods authorization) number and call tag to send the device back to precision medical.Precision medical inc was notified by the provider that they had discarded the device.Serial number provided by (b)(4) could not be physically verified by precision medical inc serial number provided by (b)(4) for model# pm4150 is 10035865 which was manufactured by precision medical in november 2017.Patient gave (b)(4) the damaged device and purchased a new device.The incident was caused by customer error.
Event or Problem Description
The client that had this unit was mowing his yard; just like he had done many times before with the poc strapped onto his back like a backpack.Not sure how; but he said he had loosened the straps and it was resting on the back seat of the mower.It must have gotten too close to the muffler as that is what the client had stated, and it blew up & caught on fire.It scared the client to death but he was unharmed.Fortunately, he was close enough to the house that he was able to get inside and get on his concentrator.

• Brand Name: EASY PULSE POC (PM4150)
• Common Device Name: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): PRECISION MEDICAL INC; 300 held drive; northampton PA 18067
• MDR Report Key: 8983275
• Report Number: 2523148-2019-00001
• Device Sequence Number: 3380379
• Product Code: CAW
• UDI-Device Identifier: 00855887006078
• UDI-Public: 00855887006078
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PM4150
• Device Catalogue Number: PM4150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other